Scientific Opinion on the revised exposure assessment of steviol glycosides (E 960) for the proposed uses as a food additive


Panel on Food Additives and Nutrient Sources Added to Food
EFSA Journal
EFSA Journal 2014;12(5):3639 [23 pp.].
Panel Members
Fernando Aguilar, Riccardo Crebelli, Birgit Dusemund, Pierre Galtier, David Gott, Ursula Gundert-Remy, Jürgen König, Claude Lambré, Jean-Charles Leblanc, Pasquale Mosesso, Alicja Mortensen, Agneta Oskarsson, Dominique Parent-Massin, Martin Rose, Ivan Stankovic, Paul Tobback, Ine Waalkens-Berendsen, Ruud Woutersen and Matthew Wright.

The Panel wishes to thank the members of the Working Group on Exposure Assessment: Polly Boon, Jürgen König, Jean-Charles Leblanc, Christina Tlustos, Christophe Matthys for the preparatory work on this scientific opinion and EFSA staff: Davide Arcella, Petra Gergelova, Alexandra Tard and Stavroula Tasiopoulou for the support provided to this scientific opinion.

Opinion of the Scientific Committee/Scientific Panel
On request from
European Commission
Question Number
2 April 2014
Published in the EFSA Journal
2 May 2014
European Food Safety Authority (EFSA), Parma, Italy

Following a request from the European Commission, the European Food Safety Authority (EFSA) carried out an exposure assessment of steviol glycosides (E 960) from its use as a food additive, taking into account the proposed extension of uses. In 2010, the EFSA Panel on Food Additives and Nutrient Sources added to Food (ANS) adopted a scientific opinion on the safety of steviol glycosides (E 960) and established an Acceptable Daily Intake (ADI) of 4 mg/kg body weight (bw) per day. Conservative estimates of exposure, both in adults and children, suggested that it is likely that the ADI would be exceeded at the maximum proposed use level. In 2011, EFSA carried out a revised exposure assessment for steviol glycosides based on revised proposed uses and concluded that high level dietary exposure in children may still exceed the ADI. The current refined exposure estimates are based on the currently authorised uses, the proposed extension, and the EFSA Comprehensive Food Consumption Database. The mean dietary exposure to steviol glycosides ranges from 0.1 mg/kg bw/day in adults and the elderly, to 2.4 mg/kg bw/day in toddlers. Estimates at the 95th percentile of exposure range from 0.3 to 4.3 mg/kg bw/day in the elderly and toddlers, respectively. The Panel concluded that dietary exposure to steviol glycosides is considerably lower than that in the previous exposure assessment. Overall, the revised exposure estimates for all age groups remain below the ADI, except for toddlers at the upper range of the high level (95th percentile) estimates, in one country. Moreover, the Panel noted that table top sweeteners may represent an important source of exposure and therefore a MPL with a numerical value, rather than quantum satis, would be preferable, to allow for a more precise estimation of the potential maximum level of exposure from table top sweeteners.

steviol glycosides, E 960, refined exposure, EFSA Comprehensive European Food Consumption Database
Print on demand
Number of Pages